Regulated document management with SharePoint

FDA compliant document and content management system optimizes collaboration across the enterprise

The Alegri solution, which is based on Microsoft Office SharePoint Server 2007 (MOSS), provides a tailored document management system that complies with FDA and 21 CFR Part 11 regulations for the pharmaceutical industry. This system encompasses the complete document lifecycle and flexibly adapts to each company's project organization. The solution supports complex search algorithms, ensures that authorized users can process documents in different locations without using multiple copies, and supports audit trail functions in line with 21 CFR Part 11. Users can easily generate document filing systems based on templates and automatically create PDF files for the long-term storage of unchangeable documents.

Standardized. Integrated. Highly accepted.

Your company can implement approximately 60 % of the requirements through configurations and the standardized functionality in SharePoint. Due to the intuitive Microsoft Office environment, acceptance among users is generally very high.

  • Strong CMS specifications / Intranet integration
  • Collaboration platform with Web 2.0 functionality
  • Workflow functions, intelligent forms
  • Seamless integration into business applications (ERP, LIMS)

This way, your company can quickly and easily attain FDA compliance!

Comprehensive. Fast. Simple.

  • Clear, project-related structuring for your company's unique organization
  • Individual, transparent security concept
  • Process support throughout the document lifecycle
  • Automatically generated PDF renditions with all workflow data

Your contact to Alegri

Dr. Andreas Jabs
Principal Consultant Alegri International Group
Tel. +49 (69) 972 66 98-123

User report

"FDA compliant Document management system at Roche Diagnostics" (German language)

Alegri at the Digital Pharma Day
www.digitalpharma.de

Alegri – Microsoft Gold Certified Partner

Alegri International Group is a leading IT consulting company with focus on all Microsoft products. With this specialization Alegri is one of the few Microsoft´s consulting partners, who professionally knows the interaction of the applications. Alegri conceptualizes and realizes professional strategic and operative solutions for large and mid-sized organizations: SharePoint, Search, Dynamics CRM, Lync, Duet, System Center, Cloud Services, .Net., etc.